Glumetza

HBSS has filed a proposed class-action lawsuit against Bausch Health Companies Inc. (formerly Valeant Pharmaceuticals), their predecessors (Salix Pharmaceuticals, Ltd., Salix Pharmaceuticals, Inc. and Santarus, Inc.), Assertio Therapeutics, Inc., Lupin Pharmaceuticals, Inc., and Lupin Ltd. for conspiring to suppress generic competition of Type 2 diabetes drug Glumetza for four years; and as a result, exorbitantly inflating the cost of brand Glumetza and, ultimately (once on the market), AB-rated generic Glumetza. By the end of July 2015, Bausch spiked the cost of Glumetza by more than 800%. As a result of this spike on the brand drug, the first generic to enter the market was also supracompetitively priced by Lupin—the manufacturer and distributor.

The complaint alleges as follows: The defendants achieved their conspiracy by entering into a pay-for-delay, no authorized generic deal. As the developer of the drug, Assertio obtained several patents that it purported to cover Glumetza. In 2009, Lupin, the first company to file an Abbreviated New Drug Application (ANDA), sought FDA approval to market its generic version of Glumetza. As the first filer, Lupin would be statutorily entitled to 180 days as the only ANDA generic on the market upon FDA approval. Assertio sued Lupin for patent infringement, alleging Lupin would infringe its patents covering Glumetza. On February 22, 2012, Assertio (along with Santarus who had assumed responsibility for the commercialization of Glumetza at the end of 2011) and Lupin settled the suit. Under their agreement, Lupin would not enter the market with its generic until February 2016, and once Lupin entered the market, Assertio/Santarus would not market an authorized generic for a year.

Two other companies filed ANDAs with the FDA, Sun Pharmaceuticals and Watson Pharmaceuticals (now-Teva Pharmaceutical Industries Ltd.), in 2011 and 2012, respectively. Assertio and Santarus initiated patent infringement suits against both companies and eventually settled both suits with an agreement that they would not enter the generic market until August 2016. Hence, the complaint alleges that not only did Lupin benefit from the already supracompetitive prices that resulted from the spike in brand Glumetza, it also benefited from the lack of an authorized generic on the market and the assurance that it would not forfeit its first filer status, which allowed it to take 100% of the generic market for at least 180 days during the exclusivity period.